Universitätsklinikum Würzburg
Ospedale san Raffaele
Universidad de Navarra
Centre Hopitalier regional et Universitaire de Lille
Bundesinstitut für Impfstoffe und Biomedizinische Arzneimittel
DRK- Blutspendedienst Baden-Wuerttemberg-Hessen GmbH
Myeloma Patients Europe
NBE Therapeutics
T-CURX GmbH
ARTTIC SAS
ARTTIC Innovation
The Team
The CARAMBA Consortium consists of eleven partners from six different European countries:
Partners
Countries
Patients
Collaboration Partner
The CARAMBA Consortium closely collaborates with partners:
Universitaetsklinikum Wuerzburg
General information
The Universitätsklinikum Wuerzburg (UKW) group is recognized internationally as a ‘Center of Excellence in Stem Cell Transplantation and Cell Therapy’, runs one of the largest leukemia (>100 acute leukemia patients per year) and stem cell transplantation programs in Germany (>280 per year) and has a designated Phase I Unit for early clinical studies. The UKW group was the first in Europe to explore T cell adoptive immunotherapy to treat infections after bone marrow transplantation in leukemia patients, and pioneered the use of bi-specific antibodies to redirect T cells to treat certain types of leukemia and lymphoma. The UKW group is already participating in several industry-sponsored clinical trials with BCMA-specific CAR-T cells in multiple myeloma and CD19- specific CAR-T cells in leukemia and lymphoma and has thus far treated the highest number of patients with CD19 CAR-T cells in Germany.
The UKW group runs one of the largest clinical programs in multiple myeloma in Europe, with more than 50 newly diagnosed patients and more than 1.000 myeloma in-patient and out-patient visits per year, and a patient registry of more than 5.000 myeloma patients. The myeloma program has a decade-long track record in the development and clinical evaluation of novel treatment concepts in myeloma and is consulted by myeloma patients that come to Würzburg from all-over Germany and Europe. A dedicated myeloma clinical service the ‘Wilhelm-Sander Therapieeinheit Multiples Myelom’ has been opened in 2015 and integrates multi-disciplinary clinical care to the benefit of myeloma patients.
The Hudecek laboratory is conducting translational research in tumor immunology and adoptive cancer immunotherapy with CAR-T cells and has garnered widespread visibility and attention in Europe and the US as a rapidly expanding, innovative research group in cell and gene therapy.
Role in CARAMBA
The Universitätsklinikum Würzburg (UKW) is the coordinating institution in CARAMBA and responsible for the successful conduct of the phase I/IIa clinical trial with SLAMF7 CAR-T cells, being an essential recruitment and treatment center. The UKW team will also lead the effort for obtaining German regulatory approval for the trial and project management.
Project staff
Michael Hudecek
Coordinator and Group Leader, Department of Internal Medicine II
Dr. Hudecek joined the University of Würzburg in 2012 as a clinical fellow and research group leader. His group is working in the field of tumor immunology and the development and clinical translation of adoptive immunotherapy of cancer with tumor-specific T cells.
Specific expertise: CAR design and evaluation; CAR/TCR Gene transfer; T cell immunotherapy; Tumor immunology.
Hermann Einsele
Full Professor of Internal Medicine, Director of the Department of Internal Medicine II
Specific expertise: Multiple Myeloma, Stem cell transplantation, Adoptive T cell therapy, Immune monitoring.
Sophia Danhof
Clinician Scientist
Leading the CARAMBA clinical trial at UKW.
Specific expertise: Hematological malignancies, Cellular therapy, SLAMF7 CAR-T cells.
Julia Beckmann
Scientist and Project Manager
Involved in clinical trial preparation.
Martin Kortüm
Clinician Scientist and Group leader involved in response assessment and monitoring.
Specific expertise: Hematological malignancies, Next-generation sequencing for risk stratification and therapeutic intervention in myeloma.
Sabrina Prommersberger
Scientist
Involved in clinical trial preparation, monitoring and next-generation CAR development.
Specific expertise: Tumor immunology, SLAMF7 CAR-T cells.
Patient Contact
TBD after trial initiation
Ospedale san Raffaele
General information
As one of the leading private scientific research institutes in Italy, recognized by the Italian Ministry of Health as a Research Hospital (IRCCS), Ospedale San Raffaele comprises both clinical and research activities, conducted by a highly specialized and qualified hospital with 1,308 beds and a research institute with more than 1,500 basic, clinical and translational scientists. OSR integrates its research with the education and training activities conducted within the Università Vita-Salute San Raffaele (UniSR) which comprises the faculties of medicine, psychology and philosophy and provides specialized post graduate courses, residency programs in various medical specialties, and international PhD programs. OSR performs cutting-edge science and aims at advancing the knowledge about human diseases and novel therapies through translational research. OSR can count on over 50 clinical specialties, 4 Research Divisions, 4 Research Institutes and 3 Research Centers. In particular OSR excellence research fields are: Oncology; Neuroscience; Metabolic and Cardiovascular Sciences; Regenerative Medicine, Stem Cells and Gene Therapy; Immunology, Transplantation and Infectious Diseases; Genetics and Cell Biology; Genomics, Bioinformatics and Imaging technologies; advanced technologies for Health and Wellbeing.
Role in CARAMBA
The Ospedale San Raffaele will be responsible for the GLP development of CARAMBA cells and the Phase I/IIa clinical study. It will also contribute to scaling-up the GMP production of cells, facilitating its regulatory approval, following up with patients and preclinical developing of next generation CAR immunotherapies.
Project staff
Fabio Ciceri
Head of the Clinical Hematology and Bone Marrow Transplantation Unit and Deputy Director of the Division of Regenerative Medicine, Stem Cell and Gene Therapy (DReAM-Gene) at OSR, and Full Professor at UniSR.
Specific expertise: more than 25 years experience in early-stage clinical development of cell and gene therapy strategies for non-malignant and malignant hematological diseases, and more recently also degenerative diseases (Duchenne muscular dystrophy) in conjunction with academic (Telethon) and non-academic (Molmed SpA, GSK) sponsors.
Monica Casucci
Senior Researcher, Innovative Immunotherapies Unit, DITID at OSR.
Specific expertise: Lead of preclinical development, expert of the CD44v6-CAR TK approach.
Marta Moresco
Project and Grant Manager
Silvia Arcangeli
Post-doctoral Researcher
Sara Mastaglio
Staff Member in the hematology and bone marrow transplant unit.
Patient Contact
Grazia Consoli
Email
Universidad de Navarra
General information
The Clínica Universidad de Navarra is a medical hospital, renowned for its high degree of specialization, ongoing technological renovation and teamwork, which allows for a personalized, multidisciplinary approach for each patient. The UNAV is a reference center in Spain for several procedures, including immunotherapy strategies. The Cellular Therapy Area (CTA) co-ordinates a multidisciplinary team of basic and clinical research in the UNAV and CIMA around the therapeutic use of advanced therapy medicinal products (ATMPs). CTA in collaboration with other centers is currently conducting several independent clinical trials with ATMPs. These immunotherapy trials are conducted in the GMP (Good Manufacturing Practices) laboratory of the CTA. The laboratory operates under strict quality system that ensures compliance with GMP. In addition, in the past 5 years the CTA group has participated as a producer laboratory in more than 20 clinical trials with different ATMPs (including clinical trials with dendritic cells). The group has actively participated in the design and development of the protocols of the clinical trials, has been responsible for the preparation of IMPDs (Investigational Medicinal Product Dossiers), IBs (Investigational Brochures), CRF (Case Report Forms) and has collaborated to get authorizations from the ethical committees and approvals of the competent authorities. The Hematology Department runs one of the largest clinical programs in multiple myeloma in Spain, with more than 30 newly diagnosed patients and more than 500 myeloma in-patient and out-patient visits per year. Lead by Professor San Miguel, a world expert, the Myeloma Program integrates clinicians, epidemiologists, specialists in clinical trials as well as researchers providing an integrated multi-disciplinary clinical care to the benefit of myeloma patients. The group of Professor San Miguel has continued uninterrupted work (>30 years) on the field of multiple myeloma (MM) with a double focus on: 1) Myeloma cell biology and its implications on prognosis and 2) MM therapeutics. Their seminal contributions on myeloma cell biology are centered on the integration of immunophenotyping, molecular cytogenetics and genomic studies to acquire a comprehensive view of the tumor clone and how biological features influence patient outcome and define new risk categories. The group also has an extensive experience on the characterization of the immunoprofiling of myeloma patients, acting as reference lab for several commercial companies as well as the Spanish myeloma group for evaluation of the immune effect of new anti-myeloma compounds.
Role in CARAMBA
Clínica Universidad de Navarra will be responsible for immune monitoring and response assessment of patients included in the clinical trial and will contribute to patient recruitment. UNAV will also participate in the development of next generation CART cells as well as generation of the ATMP product.
Project staff
Jesus San Miguel
Medical Director of UNAV, Scientific Director of CIMA and a world leader in the field of Multiple Myeloma.
Felipe Prósper
Head of Hematology and Cell Therapy and Director of the programs of Hematology and Cell Therapy at thecenter for Applied Medical Research at the University of Navarra
Specific expertise:
Epigenetic changes present in patients with hematological malignancies, mainly multiple myeloma and leukemia-MDS, Stem cell biology and stem cell therapy for human diseases.
JUAN JOSE LASARTE
Professor of Immunology at the University of Navarra and the Director of the Immunology and Immunotherapy program at CIMA.
Specific expertise:
Mechanisms of induction of cellular and humoral immune responses, development of antiviral and antitumor vaccines and therapies, development of inhibitors of immunosuppressive molecules such as TGF-beta or the transcription factor FOXP3 as well as on the design of new strategies for adoptive cell therapies.
Bruno Paiva
Principal Investigator of the Departments of Hematology and Immunology at the Clinica Universidad de Navarraand Centro de Investigaciones Medicas Aplicadas (CIMA)
Dr. Paiva is also the Director of the Flow Cytometry Core, and Scientific Coordinator of CIMA LAB diagnostics, the Laboratory Diagnostic Core of the University of Navarra, where he studied the clinical value of multiparameter flow cytometry immunophenotyping of plasma cells in multiple myeloma (MM) patients.
Specific expertise:
Multiparameter flow cytometry evaluation of hematological malignancies.
Paula Rodriguez- Otero
Clinical scientist, Department of Hematology at the University of Navarra, Member of the Myeloma Unit
Dr. Paula Rodríguez-Otero leads the clinical trials and immunotherapy program under the direction of Prof. Jesus San Miguel.
Specific expertise:
Management and biology of allogeneic stem cell transplant.
Juan Roberto Rodriguez
Principal Investigator at the Regenerative Medicine Program of the Center for Applied Medical Research (CIMA)
Specific expertise:
In vitro and in vivo genome editing strategies for the development of advanced therapies. Cell reprogramming (iPSCs) for rare disease modelling and therapy.
Patient Contact
Dra. Paula Rodriguez-Otero
Email
00 34 948 296397
Centre HoSpitalier regional et Universitaire de Lille
General information
The Lille University Hospital (CHU-Lille) is a large and experienced clinical and research facility that provides a strong infrastructure relevant for the proposed project, including one of the largest clinical myeloma programs in Europe. The department has 58 in-patients beds and 30 day-care beds with additional out-patients facilities (100 patients/day). Regarding myeloma, there are three full-time consultants dedicated to the care of myeloma patients. A large bone marrow transplantation unit performs more than 100 allogeneic transplants per year. There are three full time consultants dedicated to the management of these patients.
The clinical trial unit is led by Dr Petillon with trained trial nurses and data managers (12), experienced in both clinical trials including early phase and bone marrow transplant. Additionally, it is part of a translational research program in multiple myeloma within the URM S1128 INSERM unit and has access to a large molecular biology sequencing platform.
Role in CARAMBA
The Lille University Hospital is a participating center in the CARAMBA clinical study and an essential recruitment component and treatment center in this clinical trial. The immunology and hematology labs are able to perform all CAR-T cell enumeration and post-infusion toxicity monitoring as well as MRD by flow cytometry and NG. The CHU-Lille will also take responsibility for obtaining regulatory approval for the trial in France.
Project staff
Ibrahim Yakoub-Agha
Professor of Hematology, head of the Hematopoietic Stem Cell Transplantation Unit and past president of the Francophone Society of Bone Marrow Transplantation and Cell Therapy (SFGM-TC)
Specific expertise:
Allogeneic Stem Cell Transplantation especially in patients with Myelodysplastic Syndrome and expert in CAR-T approaches.
Myriam Labalette
Head of immunology laboratory of the Lille university hospital.
Specific expertise:
in histocompatibility and cellular immunology of hematopoetic stem cell transplantation.
Leonardo Magro
Physician at the transplantation unit at the CHRU-Lille.
Specific expertise:
in managing patients with CAR-T cells.
Salomon Manier
Instructor in Medicine; Department of Hematology, Lille University; INSERM UMR-S 1172
Specific expertise:
Investigator of several Multiple Myeloma clinical trials. Head of a research lab working on gene dependency in Myeloma.
Thierry Facon
Professor of Hematology and head of the Department of Hematology, Lille University Hospital
Specific expertise:
Lead of several pivotal clinical trials in the field of myeloma with an internationally renowned expertise is myeloma, implicated in the care of approximately 300 myeloma patients per year, 60 newly diagnosed patients and 100 relapsed and refractory patients per year.
Valerie Coiteux
Physician at the transplantation unit at the CHRU-Lille.
Specific expertise:
in managing patients with CAR-T cells.
Pauline Varlet
Biologist at the Department of Immunology and Histocompatibility.
Specific expertise:
Hematopoietic stem cell transplantation, HLA typing, T cell subset phenotyping, T cell activation, Alloreactivity
David Beauvais
Physician in the department of Hematology
Specific expertise:
in charge of CAR-T cells programme in the Hematopoietic Stem Cell Transplantation Unit
Patient Contact
Alexandra Preau
Email
Bundesinstitut für Impfstoffe und Biomedizinische Arzneimittel
General information
The Paul-Ehrlich-Institut is the Federal Institute for Vaccines and Biomedicines in Germany, employs some 800 staff, and reports to the German Federal Ministry of Health. It is the German regulatory authority in the field of vaccines and biomedicinal products assessing and monitoring the benefit-risk balance before, during and after the marketing authorisation of these medicinal products. The combination of regulatory and research tasks at the PEI is unique among the European medicines agencies. Due to this sui generis position, the institute is especially qualified to provide science-based expert advice on questions concerning the quality, efficacy, and safety of vaccines and biomedicines. Regulatory science constitutes the foundation of the institute’s regulatory decision-making. Researchers at the PEI develop new methods and major reference materials for the quality and safety testing of vaccines and biomedicines. Furthermore, they investigate the causes of unexpected adverse effects, thus playing a major part in their future prevention. This is complemented by prospective basic research projects focussing on the understanding and development of innovative prophylactic and therapeutic strategies with an emphasis on novel vaccination routes and adjuvants, the efficacy of specific immunotherapy, the potential of targeted gene and (stem) cell therapy, and the treatment of cancer by oncolytic viruses and immunotherapeutics.
PEI’s division of Medical Biotechnology focuses on four research areas:
(i) development of viral and non-viral vector systems for gene therapy,
(ii) human somatic cell therapy and tissue engineering,
(iii) xenotransplantation and
(iv) parasite (virus, transposable elements) – host cell interactions.
The research group Transposition and Genome Engineering within this division is concentrating on the development of transposon-based vector systems for regenerative medicine and gene therapy.
Role in CARAMBA
As direct research input to the CARAMBA project, the PEI will be involved in developing novel technologies for non-viral gene delivery using nano-carriers as well as next-generation Sleeping Beauty transposases, site-directed transgene integration and suicide gene switch systems.
Project staff
Zoltán Ivics
Head of Division at the Paul Ehrlich Institute, Member of the Board of the European Society of Gene and Cell Therapy (ESGCT), the German Society of Gene Therapy (DGGT) and faculty member of the Center for Cell and Gene Therapy of LOEWE.
Specific expertise:
Development and application of the Sleeping Beauty transposon system for genetic engineering.
Maximilian Amberger
PhD Student
Specific expertise:
Preclinical research on transposon based gene delivery systems with a primary focus on advancing additional safety features in form of modifying integration profiles and developing novel suicide gene switches.
Matthias Ochmann
PhD Student
Specific expertise:
Preclinical research on transposon biology and development of a next-generation hyperactive Sleeping Beauty transposase.
Csaba Miskey
Postdoctoral scientist
Specific expertise:
Several years of experience in molecular biology, high-throughput analysis and bioinformatics.
Tanja Diem
Technician
Specific expertise:
Several years of experience in molecular biology, including preparation of PCR-based libraries of transposon integration sites for next generation sequencing.
DRK- Blutspendedienst Baden-Wuerttemberg-Hessen GmbH
General information
The DRK-Blutspendedienst (DRK-BSD) is part of the German Red Cross Blood Service Baden-Württemberg-Hessen gGmbH which consists of 18 sites and institutes across Germany. It is one of the world’s largest blood services. The DRK-BSD runs state of the art GMP facilities and has long-standing expertise in GMP manufacturing, quality control, quality management and pharmaceutical regulation. As such the DRK-BSD has decade-long experience in producing blood products, cell based medicines and advanced therapeutic medicinal products (ATMPs). Several of the DRK-BSD institutes, specifically including the Frankfurt institute, are at the same time academic institutes (Goethe University, Frankfurt), combining clinical service in transfusion medicine, teaching and research/development. Thus the Professor of Translational Development of Cellular Therapeutics of Goethe University is the Head of the GMP Core Facility which is physically and organisationally located within the DRK-BSD Frankfurt institute. The DRK-BSD has developed and manufactured numerous cell-based therapies and has successfully brought three ATMPs to national marketing authorization in Germany.
Role in CARAMBA
DRK-BSD’s role within the CARAMBA consortium consists in the development of manufacturing and quality control processes for the car modified cell product, regulatory affairs, as well as the technology transfer to collaborating centers.
Project staff
Halvard Bönig
LOEWE- Professur für Translationale Entwicklung von Zelltherapeutika; Institut für Transfusionsmedizin und Immunhämatologie
Specific expertise:
LOEWE- Professur für Translationale Entwicklung von Zelltherapeutika; Institut für Transfusionsmedizin und Immunhämatologie
Annekarin Meyer
Postdoctoral Scientist/Project manager
Specific expertise:
Expert for molecular medicine with focus on immunology and tumor biology. Specialist for hematology and epigenetics. Manufacturing of ATMPs and project coordination for clinical studies (CAR-NK-cell and CAR-T-cell therapy).
Stefanie Herkt
Postdoctoral Scientist/Project manager
Specific expertise:
Biologist with focus on immunology and epigenetics. Specialist for hematology and cell therapies. Manufacturing of ATMPs and project coordination for clinical studies (CAR-NK-cell and CAR-T-cell therapy).
Address
DRK-Blutspendedienst Baden-Württemberg – Hessen gGmbH (DRK-BSD)
Sandhofstrasse 1
60528 Frankfurt, Germany
Myeloma Patients Europe
General information
Myeloma Patients Europe (MPE) plays an important role in CARAMBA through the activities related with dissemination and communication to the patient community and general population, as well as serving as the nexus with the main national patient organisations across Europe through its dense network.
MPE is an umbrella organisation of myeloma patient groups and associations. It is registered as a non-profit organisation (AISBL) under Belgian law and its headquarter is in Brussels. It currently has 41 members based in 29 countries across Europe and further afield. It also had a number of associate members from the AL amyloidosis community.
The central strategic objectives of MPE are:
- Collaborating on national and international projects that benefit the myeloma community
- Exchanging information and best practice
- Developing existing patient/carer groups and associations and facilitating the creation of new ones
- Shaping appropriate health-related policies and initiatives at European and national levels
- Ensuring patients across Europe have timely access to the medicines that will benefit them
- Stimulating and promoting patient-centred research and clinical trials
- Developing a strong evidence base on the needs and wants of myeloma patients
- Providing information, education and outreach programmes for members
MPE achieves its objectives through representing members at a European level and through providing myeloma specific knowledge and capacity building programmes. The primary purpose of these programmes is to develop a strong community of European myeloma advocates.
Role in CARAMBA
Having acquired extensive experience working with a range of stakeholders on issues such as patient involvement in drug development, optimum trial design and myeloma regulatory/reimbursement issues (including through membership to groups such as the European Medicines Agency Patient and Consumers Working Party [PCWP]), MPE can act as the main link with the myeloma patient community in Europe through its network and provide relevant patient and caregiver input to CARAMBA.
Furthermore, MPE possesses the infrastructure needed to promote education and information regarding CAR T-cell therapy and the outcomes of the CARAMBA project.
Project staff
Ananda Plate
Chief Executive Director
Specific expertise:
Several years of experience in immunology, molecular biology and cellular biology.
Kate Morgan
Policy and Public Affairs Manager
Specific expertise:
Health policy, drug regulation, reimbursement and health technology assessment, patient involvement in healthcare and patient advocacy.
Ana Vallejo
Communications Manager
Specific expertise:
Public relations, press and media work, audio-visual communication, patient advocacy, developing communication strategies.
Address
Myeloma Patients Europe AISBL
Avenue Louise 149/24
1050 Brussels, Belgium
NBE Therapeutics
General information
In December 2020, NBE-Therapeutics has been acquired by the Germany based private Pharma company Boehringer Ingelheim, and NBE is now a wholly owned subsidiary of Boehringer Ingelheim, Ingelheim, Germany. Having completed its tasks within the CARAMBA project, NBE left the CARAMBA project in 2022. Prior to its acquisition, NBE was a Swiss SME that has been founded in 2012, currently employing 23 employees, that has developed a variety of technology platforms for the development of antibodies and next-generation antibody drug conjugates for improved cancer therapy. Dr. Ulf Grawunder, CEO of NBE-Therapeutics and successful Biotech entrepreneur has more than 15 years of commercial expertise in the field of developing antibody-based anti-cancer therapeutics. Using NBE’ s antibody discovery development and engineering capabilities, NBE can on one hand provide optimal binding domains and/or input for the optimal design of specific for the SLAMF7 target, as well as providing input in the design of the optimal CAR format. Also, NBE has developed proprietary technologies for the development of site-specifically conjugated ADCs coupled to ultra-potent anthracycline toxophores. Lastly, because NBE has been commercially active for 5 years in the antibody and ADC development field, significant expertise has been accumulated in developing business and IPR strategies for biologic drug development, and in analyzing FTOs inrelevant hemato-oncological indications, including Multiple Myeloma.
Role in CARAMBA
NBE was involved in the development of a safety mechanism for controlling SLAMF7 CAR-T cell products by development/engineering of anti-SLAMF7 CAR antibody drug conjugates (ADCs). Further, NBE contributed significantly to the identification and protection of intellectual property from results of the CARAMBA project and commercial translation of the SLAMF7 CAR-T cell products.
Project staff
Ulf Grawunder
CEO NBE Therapeutics
Specific expertise:
Commercial expertise in building Biotech start-up companies in the area of antibody discovery and development.
Emile Frugier
Intellectual property manager at NBE and responsible for the development of IPR strategies and FTO analyses
Specific expertise:
Intellectual property management, commercial and entrepreneurial expertise.
Manfred Briendl
Research Associate
Supporting the ADC conjugation process.
Ina Hellmann
Group leader at NBE with the responsibility of development of ADCs in the indication of various hematological malignancies, incl. Multiple Myeloma
Specific expertise:
Expert in antibody and ADC development and immune-oncology.
Roger Beerli
CSO NBE Therapeutics
Responsible for the coordination of the Research and Discovery Programs at NBE.
Rémy Gébleux
Research Scientist II and Group leader
Responsible for ADC development and conjugation.
Address
NBE-Therapeutics Ltd.
Hochbergerstrasse 60C
4057 Basel, Switzerland
T-CURX GmbH
General information
T-CURX has been incorporated in 2017 as a high-tech life-science spin-off of the University of Würzburg, Germany, with the objective to develop and to bring curative CAR-T cell immunotherapies to the market for the benefit of large numbers of cancer patients (hence the name: T = T cell, CUR=cure, X=by transplantation). The company is located at the Innovations und Gründerzentrum (IGZ, engl.: Innovation and Start-up Center Würzburg, Germany). The academic founders of T-CURX have received the prestigious m4 Award of the Free State of Bavaria in 2016, acknowledging their innovation potential and competitiveness in the rapidly evolving CAR-T space.
The T-CURX founders and staff have the expertise and know how to lead the comprehensive market and competitor analyses, on which basis the business concepts for a going-to-market strategy and the commercial translation by T-CURX can be implemented.
T-CURX is a new spin-out and is on a trajectory for rapid expansion. It is anticipated that T-CURX will rapidly reach the operational capacity in order to adopt the SLAMF7 CAR-T cell product after completion of phase I/IIa safety/efficacy testing in CARAMBA and will be able to lead the subsequent development of the cell product to market authorization – either alone or in collaboration with major biotech or pharma positioned in the myeloma space.
Role in CARAMBA
T-CURX leads the identification and protection of intellectual property, market and competitor research in the field of CAR-T cells in myeloma, as well as the development of reimbursement and business models for the SLAMF7 CAR-T cell products. Further, T-CURX shall lead the development to market authorization and commercial translation of the SLAMF7 CAR-T cell product after completion of the Phase I/IIa clinical trial in CARAMBA.
Project staff
Christian SÖLLNER
Managing Director
Specific expertise:
Biotech & industry leadership; Legal and regulatory affairs, Business development, Intellectual property management and protection
ARTTIC SAS
General information
ARTTIC is the leading European group providing consultancy and management services to international technology-related partnerships. The ARTTIC group comprises several companies with offices in France, Belgium, Germany, the UK and Israel. ARTTIC has gathered experience and knowledge in various RDI fields. Through its involvement in more than 300 RDI projects and networks from previous EU-funding research programs, ARTTIC has developed substantial methods and tools in managing collaborative RDI projects. In the framework of FP6, FP7 and H2020, ARTTIC has managed or is currently involved in the management of more than 50 successful projects.
Role in CARAMBA
ARTTIC will be responsible for providing the infrastructure and maintenance of the project management and
communication tools which are being used in CARAMBA. This includes the project specific sharepoint platform,
telecommunication tools, project management tools and budget management tools.
Project staff
Annette Ringwald
Managing Director and Senior Consultant
Specific expertise:
Managing Director and Senior Consultant, with ARTTIC since 2001, has a vast experience with the set-up and
management of European collaborative projects, mainly in the Health sector.
ARTTIC Innovation GmbH
eneral information
ARTTIC Innovation GmbH is a spin-off of ARTTIC SAS, which has successfully been managing large-scale research and innovation projects since its foundation in 1987. In close to 33 years of company history, ARTTIC set-up and managed more than 400 projects in EU funding programmes from FP 2 to Horizon 2020. ARTTIC Innovation GmbH builds on this experience and bundles the company’s activities in Germany, which have been built and continuously strengthened since 2006.
The service offer comprises provision of hands-on support, competent advice, and added value services all along the innovation life cycle: from the definition of a project idea and -concept, the identification of a suitable funding scheme and the proposal development, to the management of the project and the dissemination and exploitation of the project results. Support for the newly introduced R&D tax credit scheme (Forschungszulagengesetz) introduced in Germany on 1st January 2020 is seamlessly integrated in the company with relevant expertise from the local and national innovation instruments to the large international collaborative undertakings.
ARTTIC SAS and ARTTIC Innovation GmbH are subsidiaries of the PNO Group, one of the biggest consultancy companies for publicly funded research and innovation projects.
Role in CARAMBA
ARTTIC Innovation GmbH is running the CARAMBA Project Office through which it will provide the methods, tools and operational support to promote an effective collaboration within the consortium. It will support the consortium in the daily management, administrative and contractual tasks to ensure the project is properly monitored and decisions and actions are prepared and taken according to the project’s progress. ARTTIC Innovation GmbH aims at simplifying the contractual and administrative work requested from the researchers as much as possible. Furthermore, ARTTIC Innovation GmbH supports project communication, dissemination, IPR management and exploitation activities.
Project staff
Sandra Annetzberger
Project Manager
Specific expertise:
International project management with focus on health collaboration projects. Expert for proposal development, contracts negotiation, project and finance controlling, extended knowledge of regulatory requirements and clinical trials in EU projects.
Patrizia Torremante
Senior Consultant
Specific expertise:
International Projects Management with more than 13 years of experience in EC-funded research projects. Specialized on the comprehensive project management from conception of the application to final reporting and closure of projects, including contractual management, project and finance controlling and reporting, as well as communication and dissemination activities in FP7 and H2020.
Address
ARTTIC Innovation GmbH
Oskar-von-Miller Ring 29
80333 Munich
Germany
FGK Clinical Research GmbH
General information
FGK Clinical Research is an owner driven full-service CRO headquartered in Munich, Germany. FGK was founded in 2002 and currently has more than 170 employees. Covering all phases and all areas of clinical development, FGK’s focus is on phase II and III trials. FGK has experience in all important medical indications, including in particular in oncology, cardiology, neurology, dermatology, and gastroenterology. Broad knowledge in highly innovative developments such as with ATMPs and GMOs, cell therapy projects and biologics completes FGK’s expertise. FGK directly leads and supervises international clinical trials and operates Europe-wide, with staff located in the headquarters in Munich, Germany as well as in the subsidiaries in Berlin, Prague, Budapest, and Warsaw.
Role in CARAMBA
FGK guides through the clinical trial process from planning and approval to the final report and supports the CARAMBA team with a full range of clinical services: From the beginning on FGK was involved with regard to consultative activities as well as Regulatory Affairs. FGK covers the clinical trial project management and monitoring, medical safety, data management and Biostatistics. Medical Writing Services and the coordination of respective eSolutions complete the services necessary to succeed in this project.
Address
FGK Clinical Research GmbH
80339 Munich, Germany
+ 49 (0) 89 893 119-0
